(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer
← catalyst calendarNCT05607004 · readout ≤ 103 d
Sponsored by Atossa Therapeutics, Inc. (industry) · ATOS — their whole pipeline →. With InClin, Inc..
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
87estimated
Sites
14
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-02-14 | actual | When the study began enrolling |
| Primary completion | Nov 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Apr 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2022-11-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-08 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Breast Neoplasms
- Invasive Breast Cancer
- Estrogen-receptor-positive Breast Cancer
- HER2-negative Breast Cancer
Interventions
- Drug: (Z)-endoxifen — also filed as endoxifen
- Drug: goserelin — also filed as Zoladex
Primary outcomes
what the primary-completion date above is the date OFPK Cohort - (Z)-endoxifen steady-state plasma concentrations
measured After 4 weeks of treatment
For Analysis of Cohort A (Treatment Cohort): determine whether the week 4 Ki-67≤10% rate is at least 65%
measured After 4 weeks of treatment
For analysis Cohort B (Treatment Cohort): determine the objective tumor response rate at 24 weeks
measured After 24 weeks of treatment
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